DL-丙氨酸的急性经口毒性和28天经口毒性研究

目的通过DL-丙氨酸的急性经口毒性和28 d经口毒性试验研究,初步判断DL-丙氨酸作为食品添加剂的安全性。方法分别按照国标的GB 15193.3-2014和GB 15193.22-2014方法来进行急性经口毒性试验和28 d经口毒性试验,然后将大鼠的各项数据进行对比分析。结果急性经口毒性试验中无毒作用表现,雌雄大鼠的经口LD5010000 mg/(kg BW)。28 d经口试验中大鼠一般状况正常,期末体重增长、进食量、食物利用率等指标未发现明显的改变;血常规、凝血、血生化及尿常规等指标均未发现有意义的异常改变;雄性高剂量组肾脏系数与对照组相比差异有统计学意义(P0.05),各剂量组间具有剂量-反应关系,其他未见异常情况;病理学检查未见与受试物有关的病理性改变。结论 DL-丙氨酸在本研究中未见毒性作用,但长期食用的安全性尚需进一步研究。

Acute oral toxicity and 28-day oral toxicity of DL-alanine

Objective To evaluate the safety of DL-alanine as a food additive by carrying out the acute oral toxicity and 28-day oral toxicity tests. Methods According to GB 15193.3-2014 and GB 15193.22-2014, acute oral toxicity test and 28-day oral toxicity test of DL-alanine were carried out, respectively. Then the data of the rats were compared and analyzed. Result The LD50 values of male and female rats were more than 10000 mg/(kg BW) according to the acute oral toxicity test. There were no toxicologically significant changes caused by DL-alanine in general condition, body weight, food consumption, hematology, hemagglutination, blood biochemistry, urinalysis, organ weight or at necropsy at the end of 28-day oral toxicity test. Relative organ weight of kidney was increased in both males and females rats, but only the high dose group and the control group showed significant differences in male rats (P>0.05), and there were no changes in other viscus. No sample-related significant changes were observed in histopathological examination. Conclusion The toxicity of DL-alanine is not found in this study, but the further studied needed to be done to ensure long-term edible safety.